Harvard Catalyst Profiles

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Jonathan Darrow, S.J.D.

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Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
  1. Darrow JJ, Kesselheim AS. Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working? Open Forum Infect Dis. 2020 Jan; 7(1):ofaa001. PMID: 32016125.
    Citations:    
  2. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 01 14; 323(2):164-176. PMID: 31935033.
    Citations:    
  3. Vargas V, Leopold C, Castillo-Riquelme M, Darrow JJ. Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile. J Glob Oncol. 2019 12; 5:1-17. PMID: 31860377.
    Citations:    
  4. Beall RF, Darrow JJ, Kesselheim AS. Approximating Future Generic Entry for New Drugs. J Law Med Ethics. 2019 Mar; 47(1):177-182. PMID: 30994060.
    Citations:    
  5. Darrow JJ, Beall RF, Kesselheim AS. The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Appl Health Econ Health Policy. 2019 02; 17(1):47-54. PMID: 30141133.
    Citations:    Fields:    
  6. Darrow JJ. Luxturna: FDA documents reveal the value of a costly gene therapy. Drug Discov Today. 2019 04; 24(4):949-954. PMID: 30711576.
    Citations:    
  7. Minssen T, Kesselheim AS, Darrow JJ. An export-only exception to pharmaceutical patents in Europe: should the United States follow suit? Nat Biotechnol. 2019 01 03; 37(1):21-22. PMID: 30605154.
    Citations:    Fields:    
  8. Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS. The US Biosimilar Market: Stunted Growth and Possible Reforms. Clin Pharmacol Ther. 2019 01; 105(1):92-100. PMID: 30415479.
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  9. Beall RF, Darrow JJ, Kesselheim AS. Patent term restoration for top-selling drugs in the United States. Drug Discov Today. 2019 01; 24(1):20-25. PMID: 30055271.
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  10. Beall RF, Darrow JJ, Kesselheim AS. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 12; 21(12):1382-1389. PMID: 30502781.
    Citations:    Fields:    Translation:Humans
  11. Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS. Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines. Health Aff (Millwood). 2018 05; 37(5):724-731. PMID: 29733717.
    Citations:    Fields:    Translation:Humans
  12. Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 06 20; 36(18):1805-1812. PMID: 29688832.
    Citations: 1     Fields:    
  13. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation - Four Years of Experience. N Engl J Med. 2018 04 12; 378(15):1444-1453. PMID: 29641970.
    Citations: 1     Fields:    Translation:Humans
  14. Sinha MS, Kesselheim AS, Darrow JJ. Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship. Chest. 2018 01; 153(1):9-11. PMID: 29307432.
    Citations:    Fields:    
  15. Darrow JJ, Fuse Brown EC, Kesselheim AS. The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health. N Engl J Med. 2018 Feb 01; 378(5):412-414. PMID: 29261363.
    Citations:    Fields:    Translation:PHPublic Health
  16. Darrow JJ, Beall RF, Kesselheim AS. Will inter partes review speed US generic drug entry? Nat Biotechnol. 2017 12 08; 35(12):1139-1141. PMID: 29220017.
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  17. Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. N Engl J Med. 2017 12 07; 377(23):2278-2286. PMID: 29211663.
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  18. Hwang TJ, Darrow JJ, Kesselheim AS. The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016. JAMA. 2017 12 05; 318(21):2137-2138. PMID: 29209711.
    Citations: 1     Fields:    
  19. Tessema FA, Darrow JJ. A New Approach to Treat Childhood Leukemia: Novartis' CAR-T Therapy. J Law Med Ethics. 2017 12; 45(4):692-697. PMID: 30027797.
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  20. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015 Sep 23; 351:h4633. PMID: 26400751.
    Citations: 18     Fields:    Translation:Humans
  21. Sarpatwari A, Darrow JJ, Kesselheim AS. Expanded access to investigational drugs. N Engl J Med. 2015 04 09; 372(15):1473-4. PMID: 25853762.
    Citations: 1     Fields:    Translation:Humans
  22. Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med. 2015 Jan 15; 372(3):279-86. PMID: 25587952.
    Citations: 14     Fields:    Translation:Humans
  23. Darrow JJ, Kesselheim AS. A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges? Food Drug Law J. 2015; 70(2):243-58, i. PMID: 26302599.
    Citations: 1     Fields:    Translation:Humans
  24. Kesselheim AS, Darrow JJ. Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era? Yale J Health Policy Law Ethics. 2015; 15(2):293-347. PMID: 26333236.
    Citations: 1     Fields:    
  25. Kesselheim AS, Darrow JJ. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes. Clin Pharmacol Ther. 2015 Jan; 97(1):29-36. PMID: 25670381.
    Citations: 5     Fields:    Translation:Humans
  26. Kesselheim AS, Tan YT, Darrow JJ, Avorn J. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct; 33(10):1770-8. PMID: 25288421.
    Citations: 2     Fields:    Translation:Humans
  27. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 07 03; 371(1):89-90. PMID: 24988576.
    Citations: 3     Fields:    Translation:Humans
  28. Darrow JJ, Kesselheim AS. Drug development and FDA approval, 1938-2013. N Engl J Med. 2014 Jun 26; 370(26):e39. PMID: 24963591.
    Citations: 6     Fields:    Translation:Humans
  29. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Mar 27; 370(13):1252-8. PMID: 24670173.
    Citations: 12     Fields:    Translation:Humans
  30. Light DW, Darrow J. Regulation of drugs for early Alzheimer's disease. N Engl J Med. 2013 07 18; 369(3):288. PMID: 23863070.
    Citations: 1     Fields:    Translation:Humans
  31. Light DW, Lexchin J, Darrow JJ. Institutional corruption of pharmaceuticals and the myth of safe and effective drugs. J Law Med Ethics. 2013; 41(3):590-600. PMID: 24088149.
    Citations: 9     Fields:    Translation:HumansPHPublic Health
  32. Jain D, Darrow JJ. An exploration of compulsory licensing as an effective policy tool for antiretroviral drugs in India. Health Matrix Clevel. 2013; 23(2):425-57. PMID: 24341078.
    Citations:    Fields:    Translation:Humans
  33. Darrow JJ. Recent developments in health law. Essential medicines: why international price discrimination may increasingly be the wrong solution to a global drug problem. J Law Med Ethics. 2011; 39(2):291-6. PMID: 21561525.
    Citations: 1     Fields:    Translation:Humans
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.